Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Jebsen Taylor Test of Hand Function
研究概览
简要总结
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.
详细描述
A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence.
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients.
Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS.
Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
- •stroke duration > 12 months
- •severe hand deficit at stroke onset (Medical Research Council grade <2) and
- •subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
- •spasticity between 0-2 assessed on the Modified Ashworth Scale
排除标准
- •any clinically significant or unstable medical disorder,
- •diagnosis od major depression,
- •diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination < 24).
- •any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants
结局指标
主要结局
Jebsen Taylor Test of Hand Function
时间窗: one day, two weeks and one month
changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately
次要结局
- hand grip force(two weeks and one month)
- upper limb Fugl-Meyer assessment of Motor Recovery after Stroke(one day, two weeks and one month)
研究者
Tihomir Ilic
Principal Investigator
Military Medical Academy, Belgrade, Serbia